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Xuan Yin Ning Plus Bevacizumab for Malignant Pleural Effusion (XYN-Bev MPE)

2026年6月29日 更新者：Zhang Ming、Shanghai Chest Hospital

A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study of Xuan Yin Ning Formula Combined With Intrapleural Injection of Bevacizumab for the Treatment of Malignant Pleural Effusion.

The goal of this clinical trial is to determine whether the Xuanyin Ning Formula combined with intrapleural injection of bevacizumab via chest tube drainage is effective in treating malignant pleural effusion. It will also evaluate the safety of this combination therapy. The main questions it aims to answer include:

Does the Xuanyin Ning Formula combined with intrapleural injection of bevacizumab via chest tube drainage improve the objective response rate (ORR) of pleural effusion in patients with malignant pleural effusion? Does this combination therapy affect the duration of response (DoR), progression-free survival (PFS), overall survival (OS), degree of dyspnea, quality of life, and Traditional Chinese Medicine (TCM) pattern/syndrome evaluation in patients with malignant pleural effusion?

Participants will:

Receive intrapleural injection of bevacizumab via chest tube drainage, and take either Xuanyin Ning Formula or placebo granules daily for 8 weeks.

Undergo ultrasound assessment of pleural effusion at 2, 4, 8, and 12 weeks after the first intrapleural injection during closed chest drainage, followed by ultrasound assessments every 3 months (±7 days) until pleural effusion progression.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

308

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Hebei
      • Wuhan、Hebei、中国、430022
        • Wuhan First Hospital
        • 接触：
    • Henan
      • Xinxiang、Henan、中国、453100
        • The First Affiliated Hospital of Xinxiang Medical University
        • 接触：
    • Shandong
      • Weifang、Shandong、中国、261041
        • Weifang Traditional Chinese Medicine Hospital 或 Weifang Traditional Chinese Hospital
        • 接触：
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200030
        • Shanghai Chest Hospital
        • 接触：
      • Shanghai、Shanghai Municipality、中国、200437
        • Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
        • 接触：
      • Shanghai、Shanghai Municipality、中国、200032
        • Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
        • 接触：
      • Shanghai、Shanghai Municipality、中国、202157
        • Shanghai Tenth People's Hospital Chongming Branch
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Patients with advanced non-squamous non-small cell lung cancer who have failed at least first-line systemic therapy;
  • Presence of unilateral pleural effusion confirmed as malignant by pathology or cytology, with at least moderate volume requiring drainage (moderate pleural effusion defined as: supine ultrasound examination showing pleural effusion ≥3 cm, or sitting ultrasound examination showing pleural effusion ≥4 cm,accompanied by clinical symptoms such as chest tightness and dyspnea);
  • Age 18-75 years;
  • ECOG performance status 0-2;
  • Traditional Chinese Medicine (TCM) syndrome differentiation classified as Xuanyin (suspension fluid) with fluid retention in the chest and hypochondrium;
  • Expected survival of at least 3 months;
  • Voluntarily signed informed consent before treatment;
  • No contraindications to chest tube placement for drainage;

  • Adequate major organ function, including:

    1. Complete blood count:

      White blood cell count ≥ 4.0×10⁹/L Absolute neutrophil count ≥ 1.5×10⁹/L Platelet count ≥ 100×10⁹/L Hemoglobin ≥ 90 g/L

    2. Blood biochemistry:

      Total bilirubin ≤ 1.5×ULN ALT ≤ 2.5×ULN, AST ≤ 2.5×ULN Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula)

    3. Coagulation function:

      International normalized ratio (INR) ≤ 1.5×ULN Activated partial thromboplastin time (APTT) ≤ 1.5×ULN

    4. Blood glucose: within normal range, or diabetic patients under treatment with stable blood glucose control;
  • Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before starting study drug administration, and must use effective contraception (e.g., intrauterine device, contraceptive pills, or condoms) during the study period and for at least 3 months after the last dose. -Male subjects with a partner of childbearing potential must use effective contraception during the study period and for 3 months after the last dose;
  • Good subject compliance, able to follow up for efficacy and adverse events/reactions as required by the protocol.

Exclusion Criteria:

  • The location of pleural effusion is unsuitable for drainage, or the patient would not benefit from intrapleural drug administration (e.g., severe loculation/septation);
  • Other contraindications to indwelling chest tube placement;
  • Pleural effusion with active infection;
  • Prior history of ipsilateral chest tube drainage and intrapleural anti-tumor drug therapy or pleurodesis;
  • Prior history of empyema or chylothorax;
  • Participation in another clinical trial within 4 weeks before signing informed consent;
  • Known allergy to any component of the study drugs;
  • Severe bleeding tendency or active bleeding;
  • Uncontrolled severe hypertension;
  • Recent (within 3 months) thromboembolic events, such as deep vein thrombosis, pulmonary embolism, cerebral infarction, etc.;
  • Prior severe adverse reactions to intravenous bevacizumab, such as severe proteinuria, gastrointestinal perforation, hypertensive crisis, etc.;
  • Severe cardiac, hepatic, or renal insufficiency;
  • Pregnant or breastfeeding women;
  • Subjects with other active infectious diseases in the acute phase;
  • Any other factors that, in the investigator's judgment, may lead to premature termination of the study, such as other serious diseases (including psychiatric disorders) requiring concomitant treatment, alcoholism, drug abuse, family or social factors that may affect the subject's safety or compliance.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：实验组
其他：Treatment with Xuanyin Ning Formula combined with intrapleural injection of bevacizumab via chest tube drainage
After chest tube drainage, bevacizumab 300 mg per dose, dissolved in 50 ml of normal saline, is injected intrapleurally. The injection may be repeated after 2 weeks depending on the control of pleural effusion. Xuanyin Ning is taken as 2 sachets per day, one sachet dissolved in water and taken orally in the morning and one in the evening. Each treatment cycle is 4 weeks, and at least 2 cycles are required.
安慰剂比较：控制组
药品：Placebo granules plus chest tube drainage and intrapleural bevacizumab injection
After chest tube drainage, bevacizumab 300 mg per dose, dissolved in 50 ml of normal saline, is injected intrapleurally. The injection may be repeated after 2 weeks depending on the control of pleural effusion. Placebo granules are taken as 2 sachets per day, one sachet dissolved in water and taken orally in the morning and one in the evening. Each treatment cycle is 4 weeks, and at least 2 cycles are required.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Objective Response Rate of pleural effusion (ORR)
大体时间：Before treatment and at 4 weeks, 8 weeks, and 12 weeks after treatment
Before treatment and at 4 weeks, 8 weeks, and 12 weeks after treatment

次要结果测量

结果测量
措施说明
大体时间
Duration of Response (DoR)
大体时间：At 2, 4, 8, and 12 weeks after treatment
At 2, 4, 8, and 12 weeks after treatment
Progression-Free Survival (PFS)
大体时间：From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall Survival (OS)
大体时间：From date of treatment until the date of death from any cause, assessed up to 100 months
From date of treatment until the date of death from any cause, assessed up to 100 months
Degree of dyspnea
大体时间：At 2, 4, 8, and 12 weeks after treatment
At 2, 4, 8, and 12 weeks after treatment
ECOG score
大体时间：At 2, 4, 8, and 12 weeks after treatment
The ECOG score is a widely used clinical tool for quantifying a cancer patient's general well-being and functional capacity in daily life. It is primarily employed in oncology trials, treatment planning, and prognosis assessment. The scale ranges from 0 to 5, with higher numbers indicating greater disability
At 2, 4, 8, and 12 weeks after treatment
Traditional Chinese Medicine (TCM) syndrome evaluation
大体时间：At 2, 4, 8, and 12 weeks after treatment

Quantification: The scale standardizes the evaluation of clinical symptoms, signs, and tongue/pulse findings, which are traditionally assessed through the four examinations (inspection, hearing/smelling, inquiry, and palpation).

Objectivity: It aims to improve the objectivity and standardization of TCM diagnosis and treatment evaluation.

Efficacy Evaluation: It is frequently used to calculate a "total effective rate" based on the reduction in syndrome scores after treatment.

Scoring: Symptoms are typically graded on a scale (e.g., 0 for normal, 2 for mild, 4 for moderate, 6 for severe), and the total score reflects the overall severity of the syndrome
At 2, 4, 8, and 12 weeks after treatment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Shanghai Chest Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月1日

初级完成 (估计的)

2028年9月1日

研究完成 (估计的)

2028年9月1日

研究注册日期

首次提交

2026年6月4日

首先提交符合 QC 标准的

2026年6月24日

首次发布 (实际的)

2026年6月26日

研究记录更新

最后更新发布 (实际的)

2026年7月1日

上次提交的符合 QC 标准的更新

2026年6月29日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • ZDYN-2024-A-147

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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